A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer

Official title

An Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection in Patients With Platinum-resistant Ovarian Cancer

Overview

This trial is an open-label, multicenter phase Ib/II clinical study of LBL-024 combination therapy in patients with platinum-resistant ovarian cancer (OC),To evaluate the efficacy and safety of LBL-024 combination therapy in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC) patients.

Detailed description

The trial was divided into two phases.

Stage I (Phase Ib): Single-Arm Safety Lead-In Period. In this stage, a small number of subjects were enrolled first and received LBL-024 combined with paclitaxel treatment, with 21 days as a cycle.Safety, tolerability and preliminary efficacy of combination drugs were assessed by the sponsor and investigators.LBL-024 Dose De-escalation Principle Based on Safety and Tolerability.

Stage II (Phase II) Randomized, Expansion Cohort Study. If safety and tolerability are good, the combined administration extension study will be continued. Subjects were continued to be enrolled in the study. The study was designed as a randomized, open-label, positive-controlled trial.Subjects who met the criteria were randomly assigned to the experimental group and the control group in a ratio of 2: 1.Experimental group (LBL-024 combined with paclitaxel) and Control group (paclitaxel monotherapy).

This study will enroll up to 110 subjects.

Interventions

• Drug LBL-024 for Injection
  LBL-024 Intravenous infusion.
• Drug Paclitaxel Injection
  Paclitaxel Intravenous infusion.

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Occurrence of adverse event (AE) and serious adverse event (SAE) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Progression-free Survival(PFS) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Secondary outcome measures (5)

• Cmax [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Tmax [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Immunogenicity [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Disease Control Rate(DCR) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Duration of Response(DOR) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Eligibility criteria

Inclusion criteria

• Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
• At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
• The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
• The expected survival time is at least 12 weeks.
• According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable lesion.
• Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug;Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Exclusion criteria

• The subject is currently participating in any other clinical trial,Or has received or is receiving other investigational agents within 4 weeks prior to the first dose of study drug.
• Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
• Patients with active infection and currently requiring systemic treatment. active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or Received anti-tuberculosis treatment within 6 months before screening.
• Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
• The patient has a Medical history of immunodeficiency, including HIV antibody positive.
• Active hepatitis B or active hepatitis C.
• Women during pregnancy or lactation.
• History of mental and/or psychiatric illness (impairing understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 13 centers

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing
• Beijing Obstetrics and Gynecology Hospital Capital Medical University — Beijing
• Fujian Cancer Hospital — Fuzhou
• Sun Yat-sen University Cancer Center — Guangzhou
• Harbin Medical University Cancer Hospital — Harbin
• AnYang Tumor Hospital — Anyang
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou
• … and 5 more centers

Identifiers

NCT: NCT07042802 · LBL-024-CN006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗